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Completed

NCT Number: NCT01653769

CoSeal for Hemostasis of Aortic Anastamoses

Surgery on the aorta can be associated with significant blood loss. Most commonly this is due to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with significant morbidity.

One way to prevent bleeding is to use a special glue (sealant) after performing large connections on the aorta. The goal of this study is to compare the different methods surgeons use to stop/prevent bleeding.

The study team will collect medical information about patients before, during, and after surgery on their aortas, including the methods used to prevent bleeding. This information may help doctors improve the way that they care for these patients.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Methodist Hospital

Houston, Texas, 77030, United States

About this study

Bleeding is a major complication of cardiac surgery, and a significant cause of morbidity and mortality [1-4]. Hemostasis can be challenging during complex cardiac surgery, particularly due to friability of the tissue, coagulopathy, poor visualization of the surgical field, and limited accessibility to bleeding sites [5]. Failure to achieve and maintain hemostasis and reinforce fragile tissue may result in additional bleeding, which can further reduce visualization, increase operative blood loss, lengthen surgery, increase the use of blood products, and contribute to postoperative complications and reoperation [1-4].

Postoperative bleeding is a significant concern in cardio-thoracic surgery. Bleeding, either intraoperative or postoperative, has been associated with extended in-hospital length of stay, reoperations, severe morbidity and death [12]. In addition to surgical technique, a variety of therapeutic agents are available to assist in hemostasis. Surgical sealants are used to prevent suture line bleeding when ligation or conventional methods are ineffective or impractical [13]. CoSeal® Surgical Sealant (CoSeal®, Baxter, Westlake Village, CA) is a synthetic polyethylene glycol (PEG) polymer [11, 13]. The polymers cross-link with proteins in the tissue and begin to gel in approximately 5 seconds and set within 60 seconds, forming a strong, flexible, clear, degradable hydrogel that adheres to both tissue and synthetic graft surfaces [11, 13-14]. A secure seal is maintained through covalent tissue bonds even under high pressures in vessels, such as the aorta [15]. The gel is completely resorbed within 30 days [14].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study will include all patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis.

Exclusion criteria

  • Patients with severe preoperative coagulopathy, connective tissue disorders and disseminated intravascular coagulopathy (DIC) will be excluded.

Treatment and study plan

Primary outcomes

  1. reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis

    Time frame: from day of surgery to 15-30 days after discharge

    estimated blood loss/chest drain output; blood product requirement during surgery; re-operation for bleeding

Secondary outcomes

  1. decrease length of stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    length of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge

Sponsors and collaborators

Lead sponsor

Michael Reardon, MD

Other

Collaborators

  • The Methodist Hospital Research Institute

Registry information

Official study title

CoSeal for Hemostasis of Aortic Anastomoses: A Propensity-Matched Cohort Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2012
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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